Managing and Disposing of Medical WasteRequirements for the management and disposal of medical waste in Texas, with links to rules, guidance, and forms.http://www.tceq.texas.gov/permitting/waste_permits/msw_permits/mw_disposal.htmlhttp://www.tceq.texas.gov/@@site-logo/tceqlogo-3colors.gif

Managing and Disposing of Medical Waste

Requirements for the management and disposal of medical waste in Texas, with links to rules, guidance, and forms.

Texas medical waste rules were revised in 2016 to implement House Bill 2244 (84th regular session of the Texas Legislature). The revised rules became effective May 26, 2016 (more information about the rulemaking).

Medical waste management includes storage, collection, handling, transportation, and processing. The rules apply to any person (as defined in 30 TAC §3.2) involved in any aspect of the management and control of medical waste, and any person that by contract, agreement, or otherwise arranges to process, store, or dispose of medical waste, or arranges with a transporter for transport to process, store, or dispose of medical waste.

A person conducting medical waste management activities may need to obtain a registration, claim a registration by rule, or submit a notification. Some medical waste management activities are exempt from registration and notification requirements.

What Wastes are Considered to be Medical Waste?

The term "medical waste" includes treated and untreated special waste from health care-related facilities that is comprised of animal waste, bulk blood, bulk human blood, bulk human body fluids, microbiological waste, pathological waste, and sharps from the sources specified in 25 TAC §1.134) , as well as "regulated medical waste" (defined in 49 Code of Federal Regulations, Part 173, §173.134(a)(5)).

The term does not include medical waste produced on a farm or ranch (as defined in 34 TAC, Chapter 3, §3.296(f)), nor does the term include artificial, nonhuman materials removed from a patient and requested by the patient, including, but not limited to, orthopedic devices and breast implants.

Health care-related facilities do not include single or multi-family dwellings, and hotels, motels, or other establishments that provide lodging and related services for the public.

Medical wastes that have been treated may be managed as routine municipal solid waste, with some exceptions.

Categories of Generators

A medical waste generator (defined in 30 TAC §326.3(14)) is any person, by site or location, that produces medical waste to be shipped to any other person, or whose act or process produces a medical waste, or first causes it to become regulated. Medical waste generators are classified into two categories:

Small quantity generator (SQG)—A medical waste generator that produces 50 pounds or less per month of medical waste; and

Large quantity generator (LQG)—A medical waste generator that produces more than 50 pounds per month of medical waste.

Storing Medical Waste On-Site

SQGs and LQGs are not required to obtain a permit, registration, notification, or other authorization to store medical waste on site, provided the waste consists only of medical waste generated on site, the waste is stored in a secure manner, and does not create a nuisance (30 TAC §326.31(a)).

Meaning of the Terms On-Site and Off-Site

Several of the rules regarding medical waste management use the terms "On-Site" and "Off-Site" in reference to the location where medical waste was generated.

On-site—Medical waste managed on property that is owned or effectively controlled by one entity and that is within 75 miles of the point of generation or generated at an affiliated facility is considered to be managed on-site (30 TAC §326.3(29)).

An "affiliated facility" is a health care-related facility that generates a medical waste that is routinely stored, processed, or disposed of on a shared basis in an integrated medical waste management unit owned, operated by a hospital, and located within a contiguous health care complex (30 TAC §326.3(2)).

Off-site—Any medical waste management practice that does not meet the criteria for on-site is considered to be off-site management.

Self-Transporting Medical Waste

SQGs may transport their own untreated waste to an authorized medical waste collection station, transfer station, storage facility, or processing facility, and are exempted from permit, registration, and notification requirements by 30 TAC §326.31(b). The SQG must initiate and maintain a record of each waste shipment collection and deposition in the form of a manifest or other similar documentation, containing the information required by §§326.53(b)(8) and (9); the SQG may use the Regulated Medical Waste Manifest (form TCEQ-310) for that purpose.

LQGs may also transport their own untreated waste to a transfer station, storage facility, or processing facility authorized to receive medical waste. LQGs that are self-transporters of medical waste must obtain a registration by rule, provide certain additional information, and submit an annual summary report in accordance with 30 TAC §326.53. The LQG must initiate and maintain a record of each waste shipment collection and deposition in the form of a manifest or other similar documentation, containing the information required by §§326.53(b)(8) and (9); the LQG may use the Regulated Medical Waste Manifest (form TCEQ-310) for that purpose.

Treatment by a Mobile On-Site Treater

Licensed Hospitals Functioning as Collection and Transfer Facilities for Generators of Small Quantities of Medical Waste

A licensed hospital may function as a medical waste collection and transfer facility for generators who generate less than 50 pounds per month of untreated medical waste, under the provisions of 30 TAC §326.43. The hospital must be located either:

In an incorporated area with a population of less than 25,000 and in a county with a population of less than one million; or

In an unincorporated area that is not within the extraterritorial jurisdiction of a city with a population more than 25,000 or within a county with a population of more than one million.

The hospital must provide written notification of the operation as a medical waste collection station, and generators must transport their own waste to the collection station. The hospital must provide the information required by 30 TAC §326.43, which may be in the form of a letter, and must acknowledge the following:

All waste received by the medical waste collection station (excluding sharps) will be packaged in accordance with the provisions of §§326.17, 326.19, and 326.21 by the generator;

Putrescible or biohazardous untreated medical waste stored for longer than 72 hours after collection will be maintained at a temperature of 45 degrees Fahrenheit or less;

Medical waste will be stored in a secure manner and location, protected from theft, vandalism, inadvertent human or animal exposure, rain, water, and wind;

The waste will be managed so as not to create a nuisance;

Medical waste will be released only to a registered medical waste transporter, and a list of the waste, including the identity of the generator will be provided to the transporter; and

Waste collected at the collection station will not be treated at the facility unless the facility is authorized to treat the waste.

Transporting Untreated Medical Waste

Untreated medical waste may be transported by the generator of the waste, or an authorized transporter other than the generator.

Untreated medical waste may be stored, processed or deposited only at a facility that has been authorized to accept untreated medical waste. Untreated medical waste that is transported out of the state must be deposited at a facility that is authorized by the appropriate agency having jurisdiction over such waste (30 TAC §326.23(f)).

Self-Transport by a Generator

Transport by a Person other than the Generator

Untreated medical waste may be transported to an authorized transporter other than the generator, following the requirements in 30 TAC §326.53. The transporter must obtain a registration by rule, and initiate and maintain a record of each waste shipment collection and deposition in the form of a manifest or other similar documentation, containing the information required by §§326.53(b)(8) and (9); the transporter may use the Regulated Medical Waste Manifest (form TCEQ-310) for that purpose.

Transporting Medical Waste by U.S. Postal Service or Equivalent Delivery Service

An authorization is not required to transport medical waste using the United States Postal Service or an equivalent delivery service in accordance with the Mailing Standards of the United States Postal Service, Domestic Mail Manual, under 30 TAC §326.31(d).

Interstate Transportation of Medical Waste

Under 30 TAC §§326.31(e), and 326.53(b)(16), persons who engage in the transportation of waste that does not originate or terminate in Texas are exempt from the medical waste rules in 30 TAC Chapter 326, except §326.53(b)(6) regarding transportation units used to collect or transport untreated medical waste.

Under 30 TAC §326.23(g), , persons that transport untreated medical waste from Texas to other states or countries or from other states or countries to Texas, or persons that collect or transport waste in Texas but have their principal place of business in another state, must comply with all applicable requirements in Chapter 326 for such transportation activities. If such persons engage in any activity of managing medical waste in Texas by storage, processing, or disposal, they must follow the applicable requirements for facility operators of such activities.

Storing Medical Waste Received from Off-Site Sources

Transferring Medical Waste

Packages of untreated medical waste may be transferred between transportation units at and on the premises of a facility authorized as a transfer station, as a storage facility, or as a treatment/processing facility that has been approved to function as a transfer station according to the provisions of 30 TAC §326.53(b)(17). Such a facility must obtain a registration as specified in 30 TAC Chapter 326, Subchapter F

Packages of untreated medical waste may also be transferred at medical waste collection stations under the conditions outlined in 30 TAC §326.43(b).

Persons transferring untreated medical waste should review information in 30 TAC §326.53(b)(18) and (19) on how to respond to a transportation unit malfunction or a traffic accident involving shipments of medical waste, and reporting requirements in those circumstances.

Treating Medical Waste

Medical waste may be treated on-site by the generator of the waste or by a person who operates a mobile, on-site treatment unit, or may be transported off-site and treated at a registered treatment facility.

Medical waste that has been treated according to the requirements of 30 TAC 326.75(r) may be managed and disposed of as routine municipal solid waste and disposed of in a municipal solid waste Type I or Type IAE landfill (described in 30 TAC §330.5(a)(1)) according to the provisions and exceptions specified in §§326.39(c), and 326.41(c), provided labeling and other requirements of §326.75(r)(1)-(5), and 25 TAC §1.136 are met.

Treated medical waste shipments including sharps or residuals of sharps originating from health care-related facilities must be accompanied by a written statement to the solid waste landfill that the shipment has been treated by an approved method in accordance with 25 TAC §1.136 (§326.23(e)).

On-Site Treatment

Treatment On-Site by the Generator

Treatment On-Site in a Mobile Treatment Unit

Medical waste may be treated on-site in a mobile treatment unit by a person who is not the generator of the waste. The owner or operator of the mobile treatment unit must follow the requirements for a registration by rule in 30 TAC §326.55.

Disposing of Medical Waste

Medical waste that has been treated according to the requirements of 30 TAC 326.75(r) may be managed and disposed of as routine municipal solid waste and disposed of in a municipal solid waste Type I or Type IAE landfill (described in 30 TAC §330.5(a)(1)) according to the provisions and exceptions specified in §§326.39(c), and 326.41(c), provided labeling and other requirements of §326.75(r)(1)-(5), and 25 TAC §1.136 are met.

Treated medical waste shipments including sharps or residuals of sharps originating from health care-related facilities must be accompanied by a written statement to the solid waste landfill that the shipment has been treated by an approved method in accordance with 25 TAC §1.136 (§326.23(e)).